With the publication of the Medical Device Regulation (EU) 2017/745 (MDR)^[1] and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR)^[2], a new role was defined according to Article 15. This is the person responsible for regulatory compliance (PRRC), who ensures that a company operates within the bounds of relevant European regulations, national law and standards. Consequently, the PRRC needs to have a deep understanding of all relevant laws and regulations that pertain to the organisation’s industry and operations related to the medical device lifecycle. To ensure a harmonised understanding of these regulations, TEAM-PRRC, a European non-profit organisation, has been created.